Safety/Efficacy of Valsartan/Hydrochlorothiazide Combination Compared to Hydrochlorothiazide in Obese Hypertensive Adults

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the blood pressure lowering efficacy of valsartan/hydrochlorothiazide (HCTZ) compared to hydrochlorothiazide for the treatment of obese hypertensive (mean sitting systolic blood pressure [MSSBP] >150 mmHg) patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Amlodipine; Hydrochlorothiazide; Valsartan

Criteria

Inclusion Criteria:

• 40 years of age or older

• Moderate or severe high blood pressure defined as systolic blood pressure (the top number) greater than or equal to 150 mmHg and diastolic blood pressure (the bottom number) less then 110 mmHg

• Central (abdominal) obesity

Exclusion Criteria:

• Systolic blood pressure (the top number) greater than or equal to 180 mmHg and diastolic blood pressure (the bottom number) greater than or equal to 110 mmHg

• Currently taking more then 3 medications to treat high blood pressure

• Inability to stop all current blood pressure medications if any up to 4 weeks

• History of Type 1 or Type 2 diabetes

• History of stroke, mini-stroke (transient ischemic attack) or heart attack within the last 6 months

• History of or current diagnosis of congestive heart failure

• History of cancer within the past 5 years with the exception of localized basal cell carcinoma or squamous cell carcinoma

• Women who are pregnant or nursing

• Alcohol or drug abuse within the last 2 years

Other protocol-defined inclusion/exclusion criteria may apply